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Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis
Objective To review patterns of publication of clinical trials funded by US National Institutes of Health (NIH) in peer reviewed biomedical journals indexed by Medline.Design Cross sectional analysis. Setting Clinical trials funded by NIH and registered within ClinicalTrials.gov (clinicaltrials.gov), a trial registry and results database maintained by the US National Library of Medicine, after 30 September 2005 and updated as having been completed by 31 December 2008, allowing at least 30 months for publication after completion of the trial.Main outcome measures Publication and time to publication in the biomedical literature, as determined through Medline searches, the last of which was performed in June 2011.Results Among 635 clinical trials completed by 31 December 2008, 294 (46%) were published in a peer reviewed biomedical journal, indexed by Medline, within 30 months of trial completion. The median period of follow-up after trial completion was 51 months (25th-75th centiles 40-68 months), and 432 (68%) were published overall. Among published trials, the median time to publication was 23 months (14-36 months). Trials completed in either 2007 or 2008 were more likely to be published within 30 months of study completion compared with trials completed before 2007 (54% (196/366) v 36% (98/269); P<0.001).Conclusions Despite recent improvement in timely publication, fewer than half of trials funded by NIH are published in a peer reviewed biomedical journal indexed by Medline within 30 months of trial completion. Moreover, after a median of 51 months after trial completion, a third of trials remained unpublished.
Journal Article
An examination of participative leadership amongst national library directors worldwide
PurposeThe purpose of this paper is to analyse managerial approaches of a selective group of national library directors, examining their views and perceptions of successful library leadership in the twenty-first century in different sociocultural contexts. This study was carried out based on a series of semi-structured interviews with ten top-level directors of national libraries located on different continents.Design/methodology/approachThe data collection method for this study consisted of the narrative analysis of the ten interviews coupled with the participative leadership theory, which highlights the leaders’ desire to create a more democratic culture within their library organisations.FindingsThe analysis of these interviews reveals that many of the directors’ responses were supportive to the concepts discussed in participative leadership. National librarians, through their participative leadership philosophies, values and beliefs, contributed to the development of an institutional culture that fostered improving trust, communications, engagement as well as promotion of inter-team relationships by breaking down the traditional “hierarchical” barriers within their organisations.Research limitations/implicationsThe participants were predominantly from Europe; only one participant represented the USA, Middle East (Israel) and Northern Africa (Egypt). As a result, there are not many diverse viewpoints from national library directors outside of Europe. Further studies would be needed to obtain a more international perspective in the national library sphere. Furthermore, this study only examines the views and attitudes of ten different library directors. In comparison with the totality of national library directors across the world, this is a relatively small sample. This study may not be representative of all national library directors around the world.Originality/valueThe results of this study would be of interest to library professionals and educators interested in management, as well as Library and Information Science students who want to understand how national library directors view successful traits of participative leadership in different sociocultural contexts.
Journal Article
Characteristics of Ophthalmology Trials Registered in ClinicalTrials.gov, 2007-2018
Purpose To perform a comprehensive analysis of characteristics of ophthalmology trials registered in ClinicalTrials.gov.Design Cross-sectional study.Methods All 4,203 ophthalmologic clinical trials registered on ClinicalTrials.gov between October 1, 2007, and April 30, 2018, were identified by using medical subject headings (MeSH). Disease condition terms were verified by manual review. Trial characteristics were assessed through frequency calculations. Hazard ratios and 95% confidence intervals were determined for characteristics associated with early discontinuation.Results The majority of trials were multiarmed (73.6%), single-site (69.4%), randomized (64.8%), and had <100 enrollees (66.3%). A total of 33% used a data-monitoring committee (DMC), and 50.6% incorporated blinding. Other groups (51.6%) were funded by industry, whereas 2.6% were funded by the US National Institutes of Health (NIH). NIH trials were significantly more likely to address oncologic (NIH = 15.5%, Other = 3%, Industry = 1.5%; P < 0.001) or pediatric disease (NIH = 20.9%, Other = 5.9%, Industry = 1.4%; P < 0.001). Industry-sponsored trials (69.6% of phase 3 trials) were significantly more likely to be randomized (Industry = 68.7%, NIH = 58.9%, Other = 60.8%; P < 0.001) and blinded (Industry = 57.2%, NIH = 42.7%, Other = 43.5%; P < 0.001). A total of 359 trials (8.5%) were discontinued early, and 530 trials (12.6%) had unknown status. Trials were less likely to be discontinued if funded by sources other than industry (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.55-0.95; P = 0.021) and/or had a DMC (HR, 0.71; 95% CI, 0.55-0.92; P = 0.010).Conclusions Ophthalmology trials in the past decade reveal heterogeneity across study funding sources. NIH trials were more likely to support historically underfunded subspecialties, whereas Industry trials were more likely to face early discontinuation. These trends emphasize the importance of carefully monitored and methodologically sound trials with deliberate funding allocation.
Journal Article
Evolution of biomedical communication as reflected by the National Library of Medicine
This commentary examines the evolution of the biomedical communications system in the Western world. The examination touches on many aspects, including the application of new technology, the interoperative relationship between publications and data, changes in the information infrastructure, the convergence of specialties, and consequences for research and health care. As an overview of communication in the biomedical sciences, this commentary draws upon studies of how science is practiced and how information is produced. For this examination, the author selected as a focus the biomedical information programs of the National Library of Medicine (NLM). This public-service organization within the US National Institutes of Health (NIH) is representative of Western biomedical information management and has produced widely used communication tools. To address the hypothesis of paradigm change, data were collected through site visits over a three month period with NLM staff. Socioeconomic issues were probed for insights into the support of science and the role of public and private sectors
Journal Article
Exploring PubMed as a reliable resource for scholarly communications services
PubMed's provision of MEDLINE and other National Library of Medicine (NLM) resources has made it one of the most widely accessible biomedical resources globally. The growth of PubMed Central (PMC) and public access mandates have affected PubMed's composition. The authors tested recent claims that content in PMC is of low quality and affects PubMed's reliability, while exploring PubMed's role in the current scholarly communications landscape.
The percentage of MEDLINE-indexed records was assessed in PubMed and various subsets of records from PMC. Data were retrieved via the National Center for Biotechnology Information (NCBI) interface, and follow-up interviews with a PMC external reviewer and staff at NLM were conducted.
Almost all PubMed content (91%) is indexed in MEDLINE; however, since the launch of PMC, the percentage of PubMed records indexed in MEDLINE has slowly decreased. This trend is the result of an increase in PMC content from journals that are not indexed in MEDLINE and not a result of author manuscripts submitted to PMC in compliance with public access policies. Author manuscripts in PMC continue to be published in MEDLINE-indexed journals at a high rate (85%). The interviewees clarified the difference between the sources, with MEDLINE serving as a highly selective index of journals in biomedical literature and PMC serving as an open archive of quality biomedical and life sciences literature and a repository of funded research.
The differing scopes of PMC and MEDLINE will likely continue to affect their overlap; however, quality control exists in the maintenance and facilitation of both resources, and funding from major grantors is a major component of quality assurance in PMC.
Journal Article
A survey of biomedical journals to detect editorial bias and nepotistic behavior
Alongside the growing concerns regarding predatory journal growth, other questionable editorial practices have gained visibility recently. Among them, we explored the usefulness of the Percentage of Papers by the Most Prolific author (PPMP) and the Gini index (level of inequality in the distribution of authorship among authors) as tools to identify journals that may show favoritism in accepting articles by specific authors. We examined whether the PPMP, complemented by the Gini index, could be useful for identifying cases of potential editorial bias, using all articles in a sample of 5,468 biomedical journals indexed in the National Library of Medicine. For articles published between 2015 and 2019, the median PPMP was 2.9%, and 5% of journal exhibited a PPMP of 10.6% or more. Among the journals with the highest PPMP or Gini index values, where a few authors were responsible for a disproportionate number of publications, a random sample was manually examined, revealing that the most prolific author was part of the editorial board in 60 cases (61%). The papers by the most prolific authors were more likely to be accepted for publication within 3 weeks of their submission. Results of analysis on a subset of articles, excluding nonresearch articles, were consistent with those of the principal analysis. In most journals, publications are distributed across a large number of authors. Our results reveal a subset of journals where a few authors, often members of the editorial board, were responsible for a disproportionate number of publications. To enhance trust in their practices, journals need to be transparent about their editorial and peer review practices.
Journal Article